Last reviewed 2026-05-23 · How we verify

eliglustat; digoxin

Genzyme, a Sanofi Company · Phase 1 active Small molecule ✓ Verified May 2026

eliglustat; digoxin is a Small molecule drug developed by Genzyme, a Sanofi Company. It is currently in Phase 1 development. Also known as: Genz-112638.

Eliglustat is a small molecule used in a Phase 1 study to evaluate its effects on the pharmacokinetics, safety, and tolerability of digoxin in healthy adults. The study, conducted by Sanofi, aimed to assess the impact of eliglustat on digoxin in a controlled setting.

Likelihood of approval

12.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
Genzyme, a Sanofi Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	eliglustat; digoxin
Also known as	Genz-112638
Sponsor	Genzyme, a Sanofi Company
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

eliglustat; digoxin CI brief — competitive landscape report
eliglustat; digoxin updates RSS · CI watch RSS
Genzyme, a Sanofi Company portfolio CI

Frequently asked questions about eliglustat; digoxin

What is eliglustat; digoxin?

eliglustat; digoxin is a Small molecule drug developed by Genzyme, a Sanofi Company.

Who makes eliglustat; digoxin?

eliglustat; digoxin is developed by Genzyme, a Sanofi Company (see full Genzyme, a Sanofi Company pipeline at /company/genzyme-a-sanofi-company).

Is eliglustat; digoxin also known as anything else?

eliglustat; digoxin is also known as Genz-112638.

What development phase is eliglustat; digoxin in?

eliglustat; digoxin is in Phase 1.

Manufacturer: Genzyme, a Sanofi Company — full pipeline
Also known as: Genz-112638

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing